Regulatory Project Director

il y a 1 jour


RisOrangis, Île-de-France Ividata Life Sciences Temps plein
Job Description

We are seeking a highly experienced Regulatory Project Director to join our team at Ividata Life Sciences.

Key Responsibilities:

  • Manage end-to-end Change Control procedure, including regulatory impact analysis and package preparation.
  • Lead OOS management for batches under stability.
  • Deliver CMC regulatory activities for clinical programs, including post-IND/IMPD submission management.
  • Manage documents through Documentum-based systems.

Requirements:

  • 10 years of CMC technical experience, with at least 5 years in lifecycle management of small molecule products.
  • Proven stakeholder management skills across asset lifecycle activities.
  • Strong project management, organizational, and authoring skills.
  • Excellent written and spoken English.

About Ividata Life Sciences:

We are a leading life sciences company dedicated to delivering innovative solutions. Our team is passionate about making a difference in the industry.



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